Clinical Research Assistant

Position Summary

The Clinical Research Assistant (RA) provides administrative support to the clinical research team and performs study coordination tasks under the direction of the principal investigator/treating investigator, under the supervision of CTO management/leadership and works closely with CTO staff, PCC staff, and other service rendering departments to ensure patient safety and overall compliance in the conduct of the study. The Research Assistant interfaces directly with patients, Principal Investigators, various departments, research teams, and sponsors in support of clinical trials as applicable.

Job Responsibilities

• Provides clerical support to assigned Disease Management Groups (DMGs), including but not limited to photocopying, faxing, filing, and scanning.
• Scans research documents into Epic EHR within 24 hours.
• Scans and emails consents and eligibility packets to Data Coordination Unit (DCU) in real time.
• Creates and maintains organizational system for shadow charts.
• Assists with coordination of research study visits for all study time points, including consent/screening and follow up.
• Schedules appointments for labs, infusion, and ancillary departments as directed by clinical research team.
• Facilities interpreter requests as needed.
• Obtains necessary signatures from PI/investigator on study-related documents in a timely manner.
• Acts as a liaison with Business Operations Unit (BOU) to assist with patient payment/reimbursement. Duties include, but are not limited to, interfacing with patients to obtain signatures on necessary forms, collecting receipts from patients, and scanning/emailing documents and receipts to BOU.
• Links patient visits to appropriate study timepoints on billing grid.
• Assists with arranging patient transportation as necessary.
• Utilizes vial assignment management systems to obtain vial assignments and communicate to Investigational Pharmacy in a timely and efficient manner.
• Access and utilize sponsor third party systems as required.
• Communicates with study sponsors to request slots, as directed by clinical research team.
• Requests medical records from outside institutions such as hospitals, medical offices, and imaging facilities.
• Assists with and coordinates the submission of Serious Adverse Events (SAEs) and other reportable events to the Data and Safety Monitoring Committee when applicable, the study sponsor, and the Institutional Review Board (IRB).
• Transports charts and other clinical supplies between NYULMC locations as necessary.
• Communicates effectively with patients and assists them in understanding/navigating non-clinical study-related concerns such as the schedule of events, trial-related reimbursement or transportation, and ancillary services (under the supervision of a licensed clinician but clinician does not have to be physically present).
• Competency in utilizing CRMS and Research Navigator for day-to-day tasks including but not limited to checking that participating PIs/Sub-Is and staff are listed on study with the IRB prior to upcoming clinical trial visits/activities.
• Completes long-term follow-up phone calls for patients requiring survival follow-up.
• Liaises and collaborates with patient navigators, investigators, various research teams to facilitate patient enrollment in clinical trials.
• Follows relevant institutional and departmental (e.g., NYU, OSR, IRB, & CTO) policies and standard operating procedures to ensure safe, compliant and quality research conduct.
• Protects patient confidentiality and PHI and complies with HIPAA.
• Demonstrates self-auditing of own work to ensure protocol compliance and patient safety.
• Utilizes principles of HRO in day-to-day work and communication to ensure safe, quality clinical research conduct.
• Supports internal audits and preparation for external audits as needed across the CTO.
• Performs other duties as assigned and additional responsibilities as needed including but not limited to cross-covering other CCU DMGs as needed.

Minimum Qualifications

• High School diploma or equivalent.
• Computer literate with good organizational, interpersonal, writing, and verbal communication skills.
• 1-year experience in a healthcare-related position required, relevant experience determined at the discretion of the Director, Clinical Operations.

Preferred Qualifications

• Associate degree, preferably in science, public health, health education, or a related field.
• 1+ year experience in research or related experience preferred.
• Experience in an oncology setting preferred.
• Experience with EPIC EHR preferred.
• Intermediate competency in Good Clinical Practice (GCP) guidelines preferred.
• Qualified candidates must be able to effectively communicate with all levels of the organization.

Pay

$53,294.21 - $55,000.00 Annually.